1. Field of the Invention
This invention relates to the prevention and treatment of dental caries, including risk assessment, activity level, intervention and materials for the measuring said risk. Advanced clinical treatment procedures, methods and materials are presented and claimed herein.
2. Background and Related Art
Dentistry is usually considered to involve the restoration of natural teeth as they become carious. Cosmetic dentistry is another concept and an option with regard to tooth whitening and in some cases, orthodontia. In the July/August 2003 Dental Practice Report, Spaeth, in an article entitled “Not your father's dentistry” quotes Dr. G. V. Black who said, in 1896, that someday dentists would be “engaged in practicing preventive, rather than reparative, dentistry”.
These sentiments were echoed in 1997, when Dr. Harold Slavkin discussed biological solutions to oral health problems including biological approaches to restorative dentistry in the repair destroyed by infection from Streptococcus mutans. There have been some patents that dealt with the idea of bacterial causes of dental decay and other problems. For example, Miehl in U.S. Pat. No. 5,213,615 uses active agents; said active agents are applied to the teeth as a dental varnish, cement, and the like. In RE 31,815 Alfano teaches a method for detecting the presence of caries in the teeth by the use of light beams of certain wavelengths and comparing the ratio of intensities of the lights in a plurality of carious and non-carious lesions in the mouth.
The prior art mentioned above dealt with advanced ways and means of the detection of carious areas of a patient's mouth. In U.S. Pat. No. 5,738,113 Connelly is concerned with the control and reduction of dental caries in people who are at risk of dental caries. Connelly discusses a method that applies fluoride and antimicrobial agents but does not provide a complete system for caries management by risk assessment.
In US patent application 20050191247, Drake et al discloses antimicrobial rinses and products based on chlorhexidine, alcohol free, xylitol and raspberry flavoring. Another US patent application 20050169852, to Roberge et al, discusses antimicrobial rinses all based on CPC, cetyl pyridium chloride.
US patent application 20050142074 to Pushpangadan et al is concerned with antimicrobial rinses based on herbs and herbal root extracts. US patent application number 20050100866 to Arnone et al shows an electronic DC probe used to determine if decay is in a tooth based on electric resistance.
In US patent application number 20050025720 Bailey shows a oral maintenance kit based on xylitol products with gum, candy, rinse, toothpaste and the like. US patent application number 20020114768 by Stoor et al discloses antimicrobial rinses based on essential oils.
U.S. Pat. No. 6,846,478 to Doyle et al discloses oral antimicrobial rinses based on chlorite ion. Applicants' invention utilizes the hypochlorite ion as an antibacterial agent in various embodiments, not the chlorite ion. Applicants' invention comprises various rinses as well as an important diagnostic component.
Dental caries recently has been considered as a complex, transmissible bacterial infection. There are multiple pathogenic, cariogenic, bacteria involved in the dental caries process. Dentistry has identified a couple of the specific bacterial pathogens, but many of the bacteria remain unidentified and not culturable in the laboratory. Consequently, this complex process is not completely understood. Current scientific research is focusing not so much on the specific bacterial pathogens, but on the cariogenic bacterial biofilm that causes the disease, and the activity potential of that biofilm.
In contrast to the previous inventions in the field, the current invention is looking for and detecting amounts and types of bacteria in the mouth. This invention includes a plurality of screening tests for the detection of Mutans streptococci and Lactobacilli in the patient's saliva and tooth surfaces. In addition to the levels of bacterial biofilm and the activity and activity potential of the bacterial biofilm it is seen as a diagnostic measure of the patient's presence of and risk for caries activity in their mouth. In this invention, one screening test is concerned with biofilm level in the mouth is determined by finding and measuring adenosine triphosphate (ATP), the energy molecule of living cells to measure the bioluminescence and to then correlate the amount of ATP present to the amount of bacterial load in the mouth.
The bacterial load in the mouth can also be measured with a second screening test, the protein detection screen; however, all teeth (even healthy teeth) are covered with a protective protein layer, the pellicle. The protein level as a determinant of the amount of bacterial biofilm present must account for the average pellicle protein baseline reading. In this invention, the presence of bacteria at high risk levels can be determined by a simple swab test looking for protein presence on the tooth surface. With a simple swab and reagent that results in a color change, bacteria on the tooth surface can be identified at high levels. The second swab test comprises a disposable protein sampler and identifying swab that changes color change indicator after swabbing. There is a color scale included with this swab test that helps to determine protein levels which are a direct result of levels of bacteria in the patient's mouth. A preferred commercially available color changing protein swab is the Biotrace Pro-Tect® system. This is a product of Biotrace Limited, located in Bridgend, in the UK. Details of the protein swab test and procedures will be described as part of the Detailed Description of the invention that follows.
The activity potential of the bacterial biofilm can be determined with the ATP bioluminescence. By taking a biofilm baseline reading of the ATP, then having the patient rinse with a specific concentration of a sugar in water solution for a specific time, then waiting a specific period of time and retesting. In a preferred embodiment, the sugar used is selected from the group consisting of sucrose and glucose, and the time period for retesting ranges from between 10 seconds and 10 minutes. The concentration of the sugar rinse used for this swab test is 0.1-40% by weight. Retesting for a second ATP level will provide a direct, calibrated, measure of the biofilm metabolic activity potential from which diagnostic decisions can be determined.
Yet another swab test that is part of this invention involves a rapid culture test for the detection of Mutans streptococci and Lactobacilli from the patient's tooth surface wherein the swab is removed from a sterile package; rubbed on a tooth surface, transferred to an agar tube selective for Mutans streptococcus, incubated at body temperature (37 degrees C.) for 3-24 hours, and read for the number of colony forming units of Mutans streptococci and Lactobacilli. 
The system of the instant invention includes a diagnostic testing component, a diagnostic survey questionnaire, and a plurality of antimicrobial treatment components. Caries risk assessment and treatment procedures are now the standard of care in California and it may become standard in other locations. Details on the components, materials and methods of the invention will be detailed shortly.